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Medical Device Certification Specialist jobs in Ontario

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    • Manage certifications and liaise with regulatory agencies as needed.
    • We are seeking a Product Compliance & Regulatory Affairs Specialist to ensure our…
    • 3 to 5 years of experience in Regulatory Affairs, Compliance, Quality, or a related function, preferably within the medical device, pharmaceutical, life…
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    • Basic understanding of global regulatory requirements for medical devices (e.g., FDA, EU MDR, ISO 13485, Health Canada SOR/98-282).
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    • A Day in the Life.
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    • Maintains working expertise in current and emerging medical device regulations, standards, and guidance documents relevant to Cognixion’s products and markets.
    • 5+ years of experience working within a regulated quality environment, preferably in medical device development and commercialization.
  • 298211 Mississauga, Ontario CA Quality Assurance…
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Job Post Details

Product Compliance & Regulatory Affairs Specialist - job post

Frontier Dental Supply
3.7 out of 5 stars
Markham, ON
$75,000–$80,000 a year - Full-time
You must create an Indeed account before continuing to the company website to apply

Job details

Pay

  • $75,000–$80,000 a year

Job type

  • Full-time

Location

Markham, ON

Benefits

Pulled from the full job description

  • Tuition reimbursement
  • Vision care
  • Dental care
  • Life insurance
  • Extended health care
  • Company events
  • On-site parking

Full job description

**Must be willing to work on-site in Markham office 5 days/week**

We are seeking a Product Compliance & Regulatory Affairs Specialist to ensure our products meet all necessary regulatory and compliance requirements across Canada and the USA.

Key Responsibilities:

  • Regulatory Compliance & Documentation Ensure all products comply with applicable regulations (e.g., FDA, Health Canada, CE, ISO, RoHS, REACH). Prepare and maintain regulatory filings, product registrations, and technical documentation. Manage certifications and liaise with regulatory agencies as needed.
  • Labeling & Safety Compliance Review product labels, packaging, and marketing materials for regulatory accuracy. Ensure proper documentation and distribution of Safety Data Sheets (SDS/MSDS).
  • Cross-functional Collaboration Work closely with Procurement, Legal, and Marketing teams to integrate compliance requirements into product development. Provide regulatory guidance for new product launches and market expansions.
  • Audits & Risk Management Support internal and external audits, inspections, and regulatory submissions. Develop and implement corrective action plans to address compliance risks.
  • Monitoring & Reporting Stay updated on changes in regulations and industry standards. Assess and communicate regulatory risks and requirements to leadership.

Qualifications & Experience:

  • Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
  • 3+ years of experience in regulatory affairs, compliance, or a related field.
  • Strong knowledge of regulatory frameworks (e.g., FDA, Health Canada, CE, ISO 13485, RoHS, REACH).
  • Experience with technical documentation, audits, and risk management.
  • Strong attention to detail, problem-solving skills, and ability to work cross-functionally.
  • Experience in the dental industry, an asset.
  • Familiarity with regulatory submission software and compliance databases.
  • Knowledge of international regulatory requirements.

Pay: $75,000.00-$80,000.00 per year

Benefits:

  • Company events
  • Dental care
  • Extended health care
  • Life insurance
  • On-site parking
  • Tuition reimbursement
  • Vision care

Work Location: In person

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